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Retrospective Review of NSAIDS in the Postpartum Period

Hypertension and NSAIDS in the Postpartum Period

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03026673
Enrollment
0
Registered
2017-01-20
Start date
2017-01-18
Completion date
2019-04-30
Last updated
2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Partum Pain

Brief summary

Chart review of women who have delivered an infant in a single health care system to determine if NSAID use increases blood pressures in the postpartum period.

Detailed description

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most common medication used for pain relief in the postpartum period in the United States. For pain relief of uterine involution, NSAIDs have shown to be superior to placebo, and equivalent or superior to narcotics. In 2013 the American College of Obstetricians and Gynecologists (ACOG) discouraged the use of NSAIDs in women with pre-eclampsia due to concerns for inadvertently increasing blood pressure. This recommendation is based on non-obstetrics literature, which tended to show a small increase of blood pressures in patients who use NSAIDS. However the literature is mixed, particularly on ibuprofen which is the most common NSAID used in the postpartum. Of the two meta-analysis that are commonly referenced, Pope et al found a decrease of -0.3 (+/- 2.57) mmHg in mean arterial pressure (MAP) in patients with hypertension treated with ibuprofen, and Johnson et al identified an average of 5mmHg increase in blood pressure with ibuprofen use. A large study of 18,325 patients who were treated with NSAIDS or COX-2 inhibitors, found an average of a 2.1 (+/- 0.5) mmHg increase in blood pressure with ibuprofen administration. There are two articles available in the obstetrics literature on the topic of NSAIDS in women with hypertension disorders. The first is by Makis et al, and is a case series of six women, with discussion of two cases. The explanations of hypertension causes are limited and possible alternate diagnoses are not discussed (6). The second by Wasden et al is a retrospective study of women who had the diagnosis of severe hypertension disorders in pregnancy. The patients were matched 2:1 for women exposed to NSAIDs versus those who did not receive NSAIDs. MAPs were compared, and there was no difference found between the two groups. This second study is better designed and is likely representative of the true outcome of NSAID use in pre-eclamptic women, as the general literature shows a small, non-clinically significant change in blood pressure readings.

Interventions

OTHERNSAID use

The purpose of the study is to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period, and thus women in the immediate postpartum period are the focus of this study.

Sponsors

St. Louis University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* received NSAIDs post delivery for pain

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
pain relief1 yearto establish that NSAIDS are an appropriate analgesic to be used in the postpartum period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026